Registration Dossier

Administrative data

Description of key information

Key studies for acute oral and dermal toxicity testing in rats and rabbits, respectively, were available for test item containing 35.8% active ingredient. LD50 values were 6500 and 3500 mg act.ingr./kg bw, respectively, therefore there is no acute toxicity hazard.  Acute inhalation toxicity was waived based upon the fact that acute inhalation exposure as such is very unlikely for sulfosuccinates due to their substance properties.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
6 500 mg/kg bw
Quality of whole database:
High quality (Klimisch 2)

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
3 500 mg/kg bw
Quality of whole database:
High quality (Klimisch 2)

Additional information

Acute oral toxicity

In a key acute oral toxicity study, groups of five male albino rats each were administered orally by stomach tube test item containing 35.8% active ingredient at 10.0, 14.7, 21.5, or 31.6mL/kg of body weight (Tusing, 1955). Rats at all dosage levels appeared depressed and exhibited labored respiration and a watery diarrhea. The surviving animals continued to exhibit these signs for 24 or 48 hours following oral administration. Thereafter, the survivors at the two lower dosage levels appeared normal, while those at the 21.5 mL/kg level appeared slightly depressed through the fifth day following dosage. Gross autopsies performed upon the animals that died showed hyperemic lungs, irritation of the gastrointestinal tract, and congested kidneys and adrenals. Surviving animals at the end of the observation period showed no significant pathology. The acute LD50 was ca. 6500 mg act.ingr./kg bw. In conclusion, there is no hazard for acute oral toxicity.

Acute dermal toxicity

In a key acute dermal toxicity, groups of four albino rabbits received a single application of test item containing 35.8% active ingredient at 1.00, 2.15, 4.64, or 10 mL/kg of body weight (Tusing, 1955). The material was applied to the closely clipped abdominal skin under rubber damming. The trunks of the animals were wrapped securely with a gauze and adhesive tape binder. After an exposure of 24 hours the binders were removed and the abdomens were sponged with water in order to remove any unabsorbed material. The animals were observed for gross signs of dermal irritation and systemic toxicity for a period of seven days, after which they were sacrificed and gross autopsies performed. There were no mortalities at any dosage level. The acute dermal LD50 was >10 mL/kg bw, corresponding to >3500 mg act.ingr./kg bw. In conclusion, there is no hazard for acute dermal toxicity.

Acute inhalation toxicity

Inhalation is very unlikely due to large particle size, low vapour pressure and high hydrophilic properties of the substance. Based on these and other physicochemical properties, the inhalation route is not appropriate; the oral and dermal route of administration are therefore applied as first and second relevant routes (ECHA R7a Guidance p 342). Additional inhalation testing would therefore neither lead to a better risk assessment, nor improve the safety of applications. On the basis of the argumentation summarized above an acute inhalation toxicity study is waived.

 

Conclusion

- Based on read across substances showing LD50values >2000 mg/kg bw, there is no hazard for acute oral and dermal toxicity

- Inhalation toxicity testing was waived based upon the fact that acute inhalation exposure as such is very unlikely.


Justification for selection of acute toxicity – oral endpoint
Key study

Justification for selection of acute toxicity – dermal endpoint
Key study

Justification for classification or non-classification

Based on these results and according to the EC Directive (No.93/21/EEC) and CLP (No. 1272/2008 of 16 December 2008), the test substance does not have to be classified and has no obligatory labelling requirement for dermal toxicity.